2436 Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Rules and Regulations 

cargo information requirements as 

provided in section 343(a) of the Trade 

Act of 2002. Truck Carrier Accounts 

participating in the test were given the 

ability to electronically transmit the 

truck manifest data and obtain release of 

their cargo, crew, conveyances, and 

equipment via the ACE Portal or 

electronic data interchange messaging. 

A series of notices announced 

additional deployments of the test, with 

deployment sites being phased in as 

clusters. Clusters were announced in the 

following notices published in the 

Federal Register: 70 FR 30964 (May 31, 

2005); 70 FR 43892 (July 29, 2005); 70 

FR 60096 (October 14, 2005); 71 FR 

3875 (January 24, 2006); 71 FR 23941 

(April 25, 2006); 71 FR 42103 (July 25, 

2006); and 71 FR 77404 (December 26, 

2006). 

CBP continues to test ACE at various 

ports. CBP will continue, as necessary, 

to announce in subsequent notices in 

the Federal Register the deployment of 

the ACE truck manifest system test at 

additional ports. 

Designation of ACE Truck Manifest 

System as the Approved Data 

Interchange System 

In a notice published October 27, 

2006, (71 FR 62922), CBP designated the 

Automated Commercial Environment 

(ACE) Truck Manifest System as the 

approved EDI for the transmission of 

required data and announced that the 

requirement that advance electronic 

cargo information be transmitted 

through ACE would be phased in by 

groups of ports of entry. 

ACE will be phased in as the required 

transmission system at some ports even 

while it is still being tested at other 

ports. However, the use of ACE to 

transmit advance electronic truck cargo 

information will not be required in any 

port in which CBP has not first 

conducted the test. 

The October 27, 2006, document 

identified all land border ports in the 

states of Washington and Arizona and 

the ports of Pembina, Neche, Walhalla, 

Maida, Hannah, Sarles, and Hansboro in 

North Dakota as the first group of ports 

where use of the ACE Truck Manifest 

System is mandated. 

ACE Mandated at Ports of Entry in 

California, Texas and New Mexico 

Applicable regulations (19 CFR 

123.92(e)) require CBP, 90 days prior to 

mandating advance electronic 

information at a port of entry, to publish 

notice in the Federal Register informing 

affected carriers that the EDI system is 

in place and fully operational. 

Accordingly, CBP is announcing in this 

document that, effective 90 days from 

the date of publication of this notice, 

truck carriers entering the United States 

at any land border port of entry in the 

states of California, Texas, and New 

Mexico will be required to present 

advance electronic cargo information 

regarding truck cargo through the ACE 

Truck Manifest System. 

Although other systems that have 

been deemed acceptable by CBP for 

transmitting advance truck manifest 

data will continue to operate and may 

still be used in the normal course of 

business for purposes other than 

transmitting advance truck manifest 

data, use of systems other than ACE will 

no longer satisfy advance electronic 

cargo information requirements at a port 

of entry in California, Texas and New 

Mexico as of April 19, 2007. 

Compliance Sequence 

CBP will be publishing subsequent 

notices in the Federal Register as it 

phases in the requirement that truck 

carriers utilize the ACE system to 

present advance electronic truck cargo 

information at other ports. ACE will be 

phased in as the mandatory EDI system 

at the ports identified below in the 

sequential order in which they are 

listed. The sequential order provided 

below is somewhat different from that 

announced in the October 27, 2006, 

notice. Although further changes to this 

order are not currently anticipated, CBP 

will state in future notices if changes do 

occur. In any event, as mandatory ACE 

is phased in at these remaining ports, 

CBP will always provide 90 days’ notice 

through publication in the Federal 

Register prior to requiring the use of 

ACE for the transmission of advance 

electronic truck cargo information at a 

particular group of ports. 

The remaining ports at which the 

mandatory use of ACE will be phased 

in, listed in sequential order, are as 

follows: 

1. All ports of entry in the state of 

New York and Michigan. 

2. All ports of entry in the states of 

Vermont, New Hampshire, and Maine. 

3. All ports of entry in the states of 

Idaho and Montana. 

4. The remaining ports of entry in the 

state of North Dakota and the land 

border port of Minnesota. 

5. All ports of entry in the state of 

Alaska. 

Dated: January 16, 2007. 

Deborah J. Spero, 

Acting Commissioner, Customs and Border 

Protection. 

[FR Doc. E7–762 Filed 1–18–07; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 800 

[Docket No. 2003N–0056 (formerly 03N–

0056)] 

Medical Devices; Patient Examination 

and Surgeons’ Gloves; Test 

Procedures and Acceptance Criteria; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

final regulation that appeared in the 

Federal Register of December 19, 2006 

(71 FR 75865). The document issued a 

final regulation that improves the 

barrier quality of medical gloves 

marketed in the United States (U.S.). 

The rule will accomplish this by 

reducing the current acceptable quality 

levels (AQLs) for leaks and visual 

defects observed during FDA testing of 

medical gloves. By reducing the AQLs 

for medical gloves, FDA will also 

harmonize its AQLs with consensus 

standards developed by the 

International Organization for 

Standardization (ISO) and ASTM 

International (ASTM). The document 

was published with some errors in the 

use of references. This document 

corrects those errors. 

DATES: This correction is effective on 

January 19, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Casper E. Uldriks, Office of Compliance, 

Center for Devices and Radiological 

Health (HFZ–300), Food and Drug 

Administration, 2094 Gaither Rd., 

Rockville, MD 20850, 240–276–0100. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

E6–21591, appearing on page 75865 in 

the Federal Register of Tuesday, 

December 19, 2006, the following 

corrections are made to the 

SUPPLEMENTARY INFORMATION. 

1. On page 75868, in the second 

column, section III of the document is 

corrected to read: 

‘‘III. Analysis of Impacts 

A. Introduction 

FDA has examined the final rule 

under Executive Order 12866 and the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 


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Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Rules and Regulations 2437 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action under the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of the rule on small 

entities. Because this final rule will not 

result in economic impacts on domestic 

small entities, the agency certifies that 

the final rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act requires that 

agencies prepare a written statement, 

which includes an assessment of 

anticipated costs and benefits, before 

proposing ‘‘any Federal mandate that 

may result in the expenditure of State, 

local and tribal governments, in the 

aggregate, or the private sector of 

$100,000,000 or more (adjusted 

annually for inflation) in any one year.’’

The current threshold after adjustment 

for inflation is $122 million, using the 

most current (2005) implicit price 

deflator for the Gross National Product. 

FDA does not expect this final rule to 

result in any 1-year expenditure that 

would meet or exceed this amount. 

The information in the following 

sections sets forth the bases for the 

previous conclusions. We show the 

expected annual costs and benefits of 

this final rule next in table 1. The 

average annualized costs of the final 

rule are estimated to be $6.6 million 

using either a 3-percent or 7-percent 

discount rate. Average annualized 

benefits are expected to be between 

$14.8 million and $15.1 million, 

depending on the discount rate. Average 

annualized net benefits are between 

$8.2 million and $8.5 million. 

TABLE 1.—AVERAGE ANNUALIZED

COSTS AND BENEFITS (IN MILLIONS)1

Annual 

Discount 

Rate 

Costs Benefits Net Benefits 

3 Percent $6.6 $14.8 $8.2 

7 Percent $6.6 $15.1 $8.5 

1Annualized over a 10-year evaluation 

period. 

B. Objective of the Final Rule 

The objective of the final rule is to 

reduce the risk of transmission of bloodborne pathogens (particularly human 

immunodeficiency virus (HIV), hepatitis 

B (HBV), and hepatitis C (HCV) 

infections). The rule accomplishes this 

objective by ensuring that medical 

gloves (surgeons’ and patient 

examination gloves) maintain a high 

level of quality with respect to the level 

of noted defects. FDA is also 

harmonizing its level for acceptable 

defects with consensus quality 

standards developed by ISO and ASTM. 

C. Current Risks of Blood-Borne Illness 

Unnecessary exposures to bloodborne pathogens are of great importance 

to the health care community because 

contact with contaminated human blood 

or tissue products has led to increased 

cases of HIV, HBV, and HCV infections. 

Available data cannot precisely 

quantify the number of new HIV cases 

that this final rule will prevent. This 

analysis, however, attempts to derive a 

conservative estimate. For the year 

2000, the Centers for Disease Control 

(CDC) reported a cumulative total of 

approximately 900,000 persons in the 

United States who had contracted HIV, 

of which 775,000 cases had progressed 

to Acquired Immunodeficiency 

Syndrome (AIDS). Of those patients 

whose conditions had progressed to 

AIDS, almost 450,000 (58 percent) had 

died as of December 2000. For the year 

2000, the CDC identified 21,704 new 

cases of HIV infection (Ref. 1). 

Approximately 5 percent of the 

reported HIV/AIDS cases were among 

health care personnel (Ref. 2). However, 

in an indepth analysis of occupational 

risk, the CDC reported that between 

1992 and 2002 there had been 56 

identified incidents of occupational 

transmission of the HIV pathogen and 

all but 7 of these cases (12.5 percent) 

were due to percutaneous cuts or 

needlesticks. In addition, there were 138 

other cases of HIV infection or AIDS 

among health care workers with 

occupational exposures to blood who 

had not reported other risk factors for 

HIV infection (Ref. 3). Assuming the 

same 12.5-percent rate for these workers 

implies that 17 additional cases of HIV 

transmission to health care workers 

during this period might have been 

caused by cutaneous contact in an 

occupational setting. Consequently, a 

total of 24 incidents of occupational 

transmission of HIV to health care 

personnel may have occurred over the 

10-year period (or 2.4 per year) due to 

problems with the barrier protection 

properties of gloves used in health care 

settings. 

The CDC also reports approximately 

80,000 new cases of HBV for the latest 

available reporting period (2001) (Ref. 

4). There are approximately 1.25 million 

people in the United States chronically 

infected with HBV. While only 6 

percent of those who contract hepatitis 

B after the age of 5 will develop chronic 

conditions, 15 to 25 percent of those 

that do will die prematurely. Health 

care personnel are at some risk from this 

pathogen, but the availability of a 

vaccine has reduced the risk of negative 

outcomes due to exposure. (Ref. 5). 

FDA has no direct data for estimating 

the rate of new HBV infections in health 

care personnel. While the CDC has 

reported the risk to health care workers 

as ‘‘low,’’ there is no definition of that 

term (Ref. 6). FDA estimates that as 

many as 4,000, or 5 percent, of all new 

incidents of HBV occur in health care 

personnel. Because occupational 

transmissions for HBV may be 

approximately 5 times more likely than 

that for HIV, FDA imputes 

approximately 140 annual cases of 

occupational transmission of HBV to 

health care personnel (HIV rate of 7.3/ 

1,085 x 5 x 4,000). CDC analyses 

communicate that a large portion of 

HBV infections in health care personnel 

are the result of direct or indirect blood 

or bodily fluid exposures that 

inoculated HBV into cutaneous 

scratches, abrasions, burns, other 

lesions, or on mucosal surfaces (Ref. 7). 

Because 2.4 of the 7.3 annual HIV 

cutaneous contact transmissions (33 

percent) were believed to be attributable 

to glove defects, FDA similarly expects 

about one-third of the 140 annual 

occupational transmissions of HBV 

infections (approximately 40 cases) may 

potentially be associated with the 

current quality level of medical gloves. 

If only 6 percent of these cases develop 

chronic conditions, then an average of 

2.4 annual cases of chronic HBV are 

associated with defective medical 

gloves. 

HCV currently infects 3.9 million 

persons in the United States. Over 2.7 

million patients have reported chronic 

conditions. (Ref. 8). More than 40,000 

new cases were reported in 1999. The 

risk of exposure to health care workers, 

however, appears to be extremely low. 

In fact, according to the CDC, other than 

from needle stick punctures, there has 

been no documented transmission of 

HCV to health care personnel from 

intact or non-intact skin exposures to 

blood or other fluids or tissues (Ref. 9). 

Thus, there is little evidence that glove 

defects are associated with HCV 

exposures. 

As a result, FDA estimates the overall 

annual transmission of blood-borne 

pathogens due to defects in glove barrier 

protection in health care settings to 

include 2.4 cases of HIV infection and 


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2438 Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Rules and Regulations 

2.4 cases of HBV infection. Increasing 

the AQL of gloves by lowering the rate 

of acceptable defects should reduce the 

transmission rates of these pathogens. 

D. Baseline Conditions 

The previous AQL (being replaced by 

this rule) for medical gloves allowed a 

defect rate of 4.0 percent for patient 

examination gloves and 2.5 percent for 

surgeons’ gloves. The AQL represents 

the proportion of sampled gloves from 

a given lot that may include defects 

such as leaks or foreign material and 

still be accepted for entry into the 

marketplace. Currently, if more than 4 

percent of the sampled patient 

examination gloves exhibit defects in 

accordance with the sampling criteria, 

the entire lot of gloves is considered 

adulterated. Surgeons’ gloves are 

sampled to a higher quality level (lower 

AQL requires a higher proportion of 

non-defective gloves in order to pass 

inspection), because these products 

have a higher likelihood of contact with 

bodily fluids. Of course, medical glove 

lots that fail to meet the AQL may be 

marketed as household or other 

products. If a sample of gloves fails to 

meet the AQL, the marketer may request 

resampling of the lot. The required 

sampling plan for a lot originally found 

to be out of compliance is more 

intensive than the original sampling 

plan for a randomly selected lot. Lots 

initially found to be out of compliance 

are either resampled and subsequently 

offered as medical devices after meeting 

the current AQL, offered as nonmedical 

gloves, or sold in foreign markets. 

Approximately 39.5 billion medical 

gloves were imported into the United 

States during 2004 (Ref. 10). According 

to FDA records, there are over 400 

manufacturers of medical gloves. 

Malaysian manufacturers supply almost 

40 percent of the medical gloves in the 

United States while Thailand 

manufacturers supply approximately 30 

percent (Ref. 11). Surgeons’ gloves 

accounted for only about 15 percent of 

all imported medical gloves during 

2004, and the impact of the final rule on 

this sector is negligibly different from 

overall patient examination gloves. 

Therefore, this analysis focuses 

exclusively on patient examination 

gloves. 

FDA expects the demand for medical 

gloves to increase by the same rate as 

employment in the medical services 

industry. The Bureau of Labor Statistics 

has projected annual employment 

growth of 2.6 percent for this industry 

(North American Industry Classification 

System 6200) (Ref. 12), which implies 

an annual volume of over 50 billion 

medical gloves in 10 years. (A 2.6 

annual growth rate results in an 

expected increase of 29.3 percent in 10 

years.) 

Medical glove lot sizes may vary from 

as few as 25 gloves to as many as 

500,000. According to discussions with 

manufacturers (Eastern Research Group, 

Inc. (ERG), 2001), a typical production 

or import lot from a foreign 

manufacturer contains an average of 

325,000 gloves (either patient 

examination or surgeons’). This implies 

that the U.S. medical glove market 

currently imports over 120,600 lots of 

gloves per year. FDA currently samples 

only about 1.5 percent of all glove lots, 

or 1,800 lots per year. Within 10 years, 

FDA expects the number of lots offered 

for import to increase to 156,000. If the 

compliance sampling rate remains 

constant, FDA would sample about 

2,300 lots during that year. 

FDA’s Winchester Engineering and 

Analytical Center (WEAC) analyzed 

results from samples collected from 

2000 and 2001. These samples represent 

approximately one-third of FDA’s total 

sampling effort for the period. (Ref. 13). 

A total of 98,067 gloves were tested 

from 942 separate lots. Of these gloves, 

2,354 were defective, which implies that 

2.4 percent of marketed gloves are likely 

to be defective. (Ref. 14) If so, then 

approximately 940 million defective 

medical gloves are currently marketed 

(39.2 billion gloves x 0.024). At the 

current AQL of 4.0, 28 lots (2.97 

percent) failed. Consequently, 

approximately 53 annually sampled lots 

are defective (1,800 sampled lots x 

0.0297). By the 10th year, in the absence 

of the final regulation, 1.21 billion 

defective gloves would be marketed and 

68 of the sampled lots would fail to 

meet the AQL. 

FDA allows glove lots that fail to meet 

the AQL to be resampled. Sponsors 

usually attempt to resample the glove 

lot rather than divert the entire lot to 

alternative markets. According to 

discussions with industry sources and 

testing laboratories, the cost of glove lot 

resampling and retesting for leakage and 

tensile strength is approximately $1,400. 

The current annual industry cost of 

resampling glove lot failures with the 

current AQL is approximately $74,000 

(53 lots times $1,400 per lot). This 

resampling and retesting cost would 

equal $95,000 within 10 years. 

E. Costs of the Final Rule 

FDA expects that the final rule will 

result in changed shipping practices by 

medical glove manufacturers. Currently, 

manufacturers use the target AQLs as a 

guide for releasing production lots of 

gloves for export to the United States 

because the release criteria are lower in 

the United States than in other markets. 

Manufacturers attempt to avoid having 

three failures within a 24–month period, 

because this may result in refusal of 

future imports under Level 3 detention 

described in FDA’s current policy, 

‘‘Surveillance and Detention Without 

Physical Examination of Surgeon’s and/ 

or Patient Examination Gloves.’’ Thus, 

to maintain an uninterrupted supply of 

gloves to customers, and to guard brand 

loyalty while avoiding Level 3 

detention, manufacturers would be 

expected to raise their level of quality 

control to at least maintain the current 

average lot rejection rate of 2.97 percent. 

FDA also expects the rule to increase 

the costs of sampling by requiring larger 

and more detailed sampling plans to 

assure the lower AQL is met for each 

inspected glove lot. FDA does not 

envision increased regulatory oversight 

costs because the rate of inspections is 

not expected to change. Costs have been 

analyzed and discounted using the 

methodology suggested by the Office of 

Management and Budget’s (OMB’s) 

Circular A–4 (September 2003). 

1. Costs of Quality Control 

Manufacturers currently conduct 

quality control tests on glove lots prior 

to release. These tests include watertight leak and tensile strength assays. 

According to interviews with glove 

manufacturers, the current cost of 

conducting these tests at the 

manufacturing site is approximately 

$310 per lot, while the more stringent 

quality control testing required by this 

rule may cost an additional $45 per lot. 

The additional cost is for increased 

inventory and larger sample sizes to 

ensure more precise measurements at 

the lower AQL. Because approximately 

120,600 lots are currently imported per 

year, the expected costs are $5.4 million 

(120,600 lots x $45 per lot). The 

expected increase in the demand for 

medical gloves by the 10th evaluation 

year will result in a compliance cost of 

meeting this increased quality level of 

$7.0 million. Over the 10-year period, 

the average annualized cost of this 

increased level of testing, at a 3-percent 

annual discount rate, is $6.2 million 

and, at a 7-percent annual discount rate, 

is $6.2 million. 

2. Increased Sampling Costs 

A lower AQL will result in increased 

sampling costs for imported glove lots. 

The increased sampling costs will result 

from the need to test greater quantities 

of gloves in order to ensure sufficient 

statistical power. Based on reported 

costs from U.S. testing laboratories, 

ERG, an independent economic 

contractor, estimated that increased 


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Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Rules and Regulations 2439 

1The current lot failure rate (28/942 = 0.0297) is 

reached by removing 53 defective lots from the 

sample. If only the 51 additional failing lots are 

removed, the overall failure rate is 0.0314 (28/891). 

The expected future failure rate is 0.0292 (26/889). 

FDA expects the withheld lots to include those with 

the highest defect rates. 

testing would add approximately $200 

to the current costs of $1,400 per 

sample. (The difference between this 

increased cost and the $45 increased 

quality control cost is attributable to 

lower costs in foreign countries that 

produce medical gloves.) FDA currently 

samples about 1.5 percent of the 

120,600 lots imported annually, or 1,800 

samples. Thus, the increased sampling 

costs due to this final rule are $0.4 

million (120,600 lots x 0.015 x $200). 

Within 10 years, this increased cost will 

equal $0.5 million (due to expected 

increases in the number of inspected 

glove lots). The average annualized 

sampling cost increase at a 3-percent 

annual discount rate is $0.4 million, and 

at a 7-percent annual discount rate is 

$0.4 million. 

3. Withheld Lots 

The lower AQL in this final rule is 

also likely to result in an increase in the 

number of lots of medical gloves that are 

not released for shipment to the U.S. 

medical market. For example, 

manufacturers may attempt to maintain 

a target compliance level in order to 

avoid FDA’s Level 3 detention under 

‘‘Surveillance and Detentions Without 

Physical Examination of Surgeon’s and 

or Patient Examination Gloves.’’ FDA’s 

WEAC laboratory sampled 942 lots and 

discovered that 28 failed using the 

current AQL while 79 lots failed using 

the lower AQL in this final rule. (Ref. 

15) To maintain the original 0.0297 (28/ 

942) lot failure rate, the 53 lots with the 

highest defect rate would have to be 

held back by the affected manufacturers 

(.056)1. 

Therefore, FDA anticipates that under 

the lower AQL in the final rule, 

approximately 6,900 lots will be held 

back by manufactures. In order to meet 

the expected demand in 10 years, FDA 

expects that 9,000 lots will be held back. 

FDA believes that glove lots that fail to 

meet the lower AQL in this final rule for 

medical quality standards will most 

likely be sold as nonmedical gloves. 

FDA believes that, although 

manufacturers and distributors may 

experience some loss of revenue from 

this shift (because of the price premium 

commanded by medical gloves), the loss 

will be inconsequential. 

4. Costs of FDA Inspections 

FDA does not envision increased 

inspection costs due to the final rule. 

The rate of sampled glove lots is not 

expected to differ and FDA resources 

are not expected to increase over the 

evaluation period. 

5. Total Costs 

In sum, FDA estimates that the final 

rule will have an average annualized 

cost of about $6.6 million using either 

a 3-percent or 7-percent annual discount 

rate. Table 2 of this document presents 

the costs for each year of the evaluation 

period. 

TABLE 2.—COSTS PER YEAR OF THE

FINAL RULE (IN MILLIONS) 

Year 

Costs for 

Quality 

Control 

Costs for 

Sampling 

Total 

Costs 

Current $5.4 $0.4 $5.8 

1 $5.6 $0.4 $6.0 

2 $5.7 $0.4 $6.1 

3 $5.9 $0.4 $6.3 

4 $6.0 $0.4 $6.4 

5 $6.2 $0.4 $6.6 

6 $6.3 $0.4 $6.7 

7 $6.5 $0.4 $6.9 

8 $6.7 $0.4 $7.1 

9 $6.8 $0.5 $7.3 

10 $7.0 $0.5 $7.5 

Present 

Values 

3%–$53.2 

7%–$43.4 

3%–$3.6 

7%–$2.9 

3%–

$56.8 

7%–

$46.3 

F. Benefits of the Rule 

The final rule will result in public 

health gains by reducing the frequency 

of blood-borne pathogen transmissions 

due to defects in the barrier protection 

provided by medical gloves. Based on 

an implied societal willingness to pay 

(WTP), FDA expects that an annualized 

monetary benefit of $14.8 million (using 

a 3-percent discount rate) or $15.1 

million (using a 7-percent discount rate) 

will be realized due to fewer pathogen 

transmissions and unnecessary blood 

screens. Fewer glove defects will reduce 

the cost and anxiety associated with 

unnecessary blood screens (i.e., those 

that would yield negative results for 

health care personnel). Benefits have 

been analyzed and discounted using the 

methodology suggested by OMB’s 

Circular A–4 (September 2003). 

1. Reductions in the Number of 

Marketed Defective Gloves 

As noted in the previous paragraphs, 

FDA has determined that approximately 

940 million defective gloves are 

marketed each year in the United States, 

or 2.4 percent of all medical gloves. In 

the absence of this rule, FDA expects 

that the number of defective medical 

gloves marketed in the United States 

would increase to 1.21 billion per year 

within 10 years. The final rule will 

substantially reduce this figure. 

WEAC’s analysis of 98,067 medical 

gloves from 942 sampled lots collected 

in 2000 and 2001 resulted in 

approximately 3-percent lot failures 

with an AQL of 4.0 (28 lots would fail). 

This lot failure rate was associated with 

2,356 defective gloves, or 2.4 percent of 

the total number of sampled gloves. 

(Ref. 16). Under the lower AQL of 2.5 

in the rule, the WEAC analysis 

concluded that 51 additional lots would 

fail (a total of 79 failed lots), increasing 

the lot failure rate from 2.91 percent to 

8.39 percent. 

As previously mentioned, FDA 

provides a Level 3 detention status in its 

guidance, ‘‘Surveillance and Detentions 

Without Physical Examination of 

Surgeon’s and or Patient Examination 

Gloves.’’ Manufacturers on Level 3 

detention are not allowed to import 

medical gloves because they have 

repeatedly failed analysis. To avoid the 

denial of entry, manufacturers may be 

expected to hold a sufficient number of 

defective lots from shipment in order to 

maintain the same target lot failure rate 

(approximately 3 percent) with a new 

AQL. If so, removing the 53 most 

defective lots in the testing sample 

would result in 26 lot failures from 880 

total lots, thereby maintaining the 

original 2.92 percent lot failure rate. 

This scenario leaves 85,172 total gloves 

in the sample, of which 1,512 were 

defective, resulting in a glove defect rate 

of 1.78 percent. The final rule, therefore, 

could reduce the proportion of marketed 

defective medical gloves from 2.4 

percent of all marketed gloves to 1.78 

percent of all marketed gloves. 

The implications of this expected 

reduction in defective gloves are 

significant. The current AQL is 

associated with 940 million glove 

defects during the present year (based 

on 2004) and within 10 years would 

result in 1.21 billion marketed defective 

medical gloves. When the lower AQL is 

in place, the current number of 

defective gloves will approximate 700 

million and within 10 years will result 

in 900 million defective marketed 

gloves. The number of defective gloves, 


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2440 Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Rules and Regulations 

therefore, should be reduced by more 

than 25 percent due to the new AQL. 

2. Reductions in Blood-Borne Pathogens 

FDA has estimated that there are 

potentially 4.8 annual transmissions of 

blood-borne pathogens associated with 

medical glove defects (section III.C of 

this document). These transmissions 

include 2.4 cases of HIV and 2.4 cases 

of chronic HBV. Because there are 

currently no documented cases of 

cutaneous transmission of HCV that 

would be affected by improving glove 

quality levels, this analysis does not 

consider potential HCV transmission. 

a. Reductions in HIV transmission. 

While the direct relationship between 

defective medical gloves and the 

transmission of HIV is unknown, FDA 

believes it is reasonable to apply the 

proportional reduction in the number of 

defective gloves due to the final rule 

(about 25 percent) to the annual 

transmission rate of the HIV pathogen to 

health care personnel. In the absence of 

this rule, the current expectation of 2.4 

annual cases of HIV transmission to 

health care personnel would likely 

increase to 3.1 annual cases within 10 

years due to the expected growth of 

employment in the health services 

industry. However, with the new AQL 

in place, FDA forecasts the expected 

annual transmission of HIV to health 

care personnel to equal 1.8 cases in 

current conditions and 2.3 cases by the 

10th evaluation year (based on the 

expected proportionate decrease in 

marketed defective gloves). Over the 

entire 10-year evaluation period, these 

assumptions suggest that the rule 

should prevent approximately seven 

cases of HIV transmission to health care 

personnel. 

b. Reductions in HBV transmissions. 

Hepatitis B transmissions to health care 

personnel are more common than 

cutaneous HIV transmissions. However, 

little specific data are available to 

identify affected patient populations 

and routes of transmission. FDA has 

estimated that as many as 2.4 cutaneous 

transmissions of chronic HBV may be 

due to defective medical gloves each 

year. In the absence of this rule, this 

number would be expected to increase 

to 3.1 annual transmissions within 10 

years, based on the expected 

employment growth in the health 

services industry. 

Implementation of the final rule 

should decrease these transmissions by 

about 25 percent. FDA expects 1.8 HBV 

transmissions under current conditions, 

a reduction of 0.6 transmissions from 

baseline conditions. By the 10th 

evaluation year, FDA expects that there 

will be 2.3 chronic HBV transmissions 

with the lower AQL, or a total of 0.8 

fewer cases. Overall, about 7 

transmissions of chronic HBV will be 

avoided due to the final rule over a 10 

year evaluation period. 

3. Reductions in the Number of Blood 

Screening Tests 

As the number of defective gloves 

marketed in the United States decreases 

due to this rule, corresponding 

reductions would be expected in the 

number of unnecessary blood screens. 

FDA contacted several research 

hospitals to ascertain how frequently 

health care personnel identify glove 

failure as a reason for initiating blood 

screens. Respondents stated that about 

5-percent of all glove failures are 

noticed by the user and about 1 percent 

of these identified failures are reported 

to the facility for additional screening 

(Ref. 17). Respondents noted that the 

glove failure could occur prior to patient 

contact. Therefore, the additional 

screening may apply to the affected 

health care personnel or the patient. The 

great majority of these screens result in 

negative findings. 

As shown in the previous paragraphs, 

when the final rule is in effect, FDA 

expects the number of defective gloves 

marketed to decrease from 940 million 

to 700 million, a reduction of 240 

million defective gloves. By the 10th 

year, the number of defective gloves is 

expected to decrease from 1.21 billion to 

900 million, a reduction of 310 million 

defective gloves. At the rates of 

potential identification (5 percent) and 

reports of contact with pathogens (1 

percent) obtained from the research 

hospital sector, the final rule should 

result in 120,000 fewer unnecessary 

blood screens under current conditions 

(240 million fewer defects x 0.05 x 

0.01). By the 10th year, 155,000 fewer 

annual blood screens are expected. Over 

the entire evaluation period, the rule 

could result in over 1.4 million fewer 

unnecessary blood screens. 

4. Cost-Effectiveness of the Final Rule 

We analyzed the cost-effectiveness of 

the final rule using both the cost per 

transmission of blood-borne pathogen 

avoided and the cost per unnecessary 

blood screen avoided. The annual 

numbers of future avoided 

transmissions and tests were compared 

to the present values of the costs for the 

evaluation period and shown in table 3. 

Table 3 of this document shows the 

expected annual reductions in bloodborne pathogens and unnecessary blood 

screens due to the final rule. 

TABLE 3.—EXPECTED ANNUAL REDUCTIONS IN BLOOD-BORNE PATHOGEN

TRANSMISSIONS AND UNNECESSARY

BLOOD SCREENS

Year 

Reduction in 

Blood-Borne 

Pathogen Transmission 

Reduction in 

Unnecessary 

Blood 

Screens 

Current 1.2 120,000 

1 1.2 120,000 

2 1.2 125,000 

3 1.4 135,000 

4 1.4 135,000 

5 1.4 140,000 

6 1.4 145,000 

7 1.6 150,000 

8 1.4 145,000 

9 1.6 155,000 

10 1.6 155,000 

Although these reductions should 

continue beyond the evaluation period, 

we have analyzed only through the 10th 

year. Each year’s expected number of 

reduced blood-borne pathogen 

transmissions and unnecessary blood 

screens are discounted (using both a 3- 

percent annual discount rate and a 7- 

percent annual discount rate) to arrive 

at an equivalent number of reductions if 

valued during the first evaluation year. 

The present values of the regulatory 

costs (shown in table 4 of this 

document) are divided by the present 

values of the expected reductions to 

arrive at the cost per avoided event. 

This is shown in table 4 of this 

document. 


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2The implication is that an ideal health state is 

valued as 1.0000 and mortality at 0.0000. Each 

functional state between these extremes is a 

proportionate value of ‘‘perfect’’ health. 

TABLE 4.—REGULATORY COST-EFFECTIVENESS PER INCIDENCE OF BLOOD-BORNE PATHOGEN TRANSMISSION AVOIDED

AND UNNECESSARY BLOOD SCREEN AVOIDED

Annual Discount 

Rate 

Present Value of 

Costs (in millions) 

Present Value of BloodBorne Pathogens Avoided Cost per Blood-Borne 

Pathogen Avoided (in 

millions) 

Present Value of Blood 

Screens Avoided 

Cost per Blood 

Screen Avoided 

3 percent $56.8 12.2 $4.7 1,191,000 $48 

7 percent $46.3 9.8 $4.7 971,000 $48 

The cost-effectiveness of the final rule 

is $4.7 million per transmission of 

blood-borne pathogen avoided, or $48 

per unnecessary blood screen avoided 

for both discount rates. We note that 

both reductions should occur and the 

allocation of costs to each outcome 

would reduce the costs per avoided 

event for both. 

5. Value of Avoiding Blood-Borne 

Pathogens 

a. Quality adjusted life-years. The 

economic literature includes many 

attempts to quantify societal values of 

health. A widely cited methodology 

assesses wage differentials necessary to 

attract labor to riskier occupations. This 

research indicates that society appears 

to be WTP approximately $5 million to 

avoid the probability of a statistical 

death (Ref. 18). That is, social values 

appear to show that people are WTP a 

significant amount to reduce even a 

small risk of death; or similarly, to 

demand significant payments to accept 

marginally higher risks. 

Because this estimate is 

predominantly based on blue-collar 

occupations that mainly attract males 

between the ages of 30 and 40, FDA 

adjusted the life-expectancy of a 35- 

year-old male to account for future bed 

and non-bed disability (Ref. 19), and 

amortized the $5 million (at both 3- 

percent and 7-percent discount rates) 

over the resulting quality-adjusted life 

span. The results were estimates of 

$213,000 per quality adjusted life-year 

(QALY) using a 3-percent discount rate 

and $373,000 per QALY using a 7- 

percent discount rate, which implies 

that society is WTP between $213,000 

and $373,000 for the statistical 

probability of a year of perfect health, 

depending on the discount rate. 

b. Value of morbidity losses. In 

theory, loss of health reduces the WTP 

for additional longevity. Many studies 

have attempted to estimate the relative 

loss of health for many different 

conditions of morbidity. One method 

utilizes the Kaplan-Bush Index of WellBeing. This index assigns relative 

weights to functional states, and then 

adjusts the resulting weighted value by 

the problem/symptom complex that 

contributed to loss of function (Ref. 20). 

Functional state is measured in three 

areas: Mobility, social activity, and 

physical activity. For example, with 

most treatment, chronic HBV is unlikely 

to have a major impact on any of these 

functions; a patient could drive a car, 

walk without a physical problem, and 

conduct work, school, housework and 

other activities. However, because a 

patient with HBV has an ongoing 

problem/symptom complex, the relative 

weight of this functional state is 

0.74332. (Ref. 21). 

This methodology then adjusts the 

weighted value of the functional state by 

the most severe problem/symptom 

complex contributing to that state. In 

the case of chronic HBV, the most 

common symptom is general tiredness, 

weakness, or weight loss. This complex 

has a derived relative weight of +0.0027, 

which when added to the weighted 

functional state value results in a 

relative weight of 0.7460. The loss of 

relative health due to HBV, therefore, is 

expected to equal 1.0000 minus 0.7460, 

or 0.2540 of perfect health. When this 

relative health loss is applied to the 

derived value of a QALY, it implies that 

society would be WTP between $54,000 

(3 percent) and $93,000 (7 percent) per 

year to avoid a case of HBV (QALY 

value x 0.2540). This value includes the 

potential costs of treatment and 

additional prevention, as well as any 

perceived pain and suffering. 

FDA compared this methodology to a 

variety of published estimates of 

preference ratings of morbidity prepared 

by the Harvard Center for Risk Analysis 

(HCRA). The published ratings of 14 

studies of chronic HBV ranged from 

0.75 to 1.00 (no impact) (Ref. 22). While 

the estimate used in this analysis (0.746) 

is in the low end of collected published 

studies, FDA notes that most of the 

expressed preferences that were derived 

from time trade-off and standard gamble 

methodologies, as compared to author 

judgment, were closer to the FDA 

estimate. A health care worker who may 

contract HBV may typically have a life 

expectancy of approximately 40 years 

(as of the year 2000, a 40-year-old 

female had a future life expectancy of 

41.1 years (Ref. 23)). The present value 

(PV) of $54,000 (3 percent) and $93,000 

(7 percent) for 40 years implies that 

society is WTP $1.25 million (3 percent) 

or $1.24 million (7 percent) to avoid the 

statistical likelihood of a case of chronic 

HBV in health care personnel. 

Deriving society’s implied WTP to 

avoid HIV is more complicated. The 

CDC has published data indicating that 

approximately 80 percent of all HIV 

infections progress to AIDS within 5 

years. Of the cases of AIDS, over half 

(approximately 60 percent) result in 

mortality within an additional 5 years. 

Thus, for a 10 year period, FDA tracked 

3 potential outcomes: Patients who 

contract HIV but do not progress to 

AIDS (20 percent), patients who 

contract HIV and progress to AIDS in 5 

years and survive (32 percent), and 

patients who contract HIV, progress to 

AIDS within 5 years and then die within 

an additional 5 years (48 percent). 

HIV infection is not expected to affect 

either mobility or social activity. 

However, such an infection is likely to 

somewhat inhibit physical activity. HIV 

patients are expected to be able to walk, 

but with some physical limitations. This 

functional state has a relative weight of 

0.6769. The main problem/symptom 

complex of HIV is general tiredness (as 

for HBV), so the selected functional 

weight is adjusted by +0.0027 to result 

in relative well-being of 0.6796. As a 

result, the relative societal WTP to avoid 

the statistical probability of a case of 

HIV in health care personnel is 

approximately $68,000 (3 percent) or 

$120,000 (7 percent) per year (QALY 

value x (1.0000 minus 0.6796)). 

According to the collected preference 

scores in the HCRA’s Catalog of 

Preference Scores, the average estimated 

published preference rating for HIV 

infection was 0.7 (range 0.3 to 1.00). 

(Ref. 24). 

If HIV progresses to AIDS, a patient’s 

functional state is likely to be more 

restricted. An AIDS patient requires 

some assistance with transportation, is 

limited in physical activity, and is 

limited in work, school, or household 


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activity. The relative weight for this 

functional state is 0.5402. The main 

problem/symptom of AIDS remains 

general tiredness and loss of weight (as 

with HIV and HBV), so the adjusted 

health state is 0.5429. This results in a 

derived societal WTP to avoid the 

statistical probability of a case of AIDS 

of about $97,000 (3 percent) or $170,000 

(7 percent) per year (QALY value x 

(1.0000 minus 0.5429)). The HCRA’s 

Catalog of Preference Scores reports 

average preference ratings of 0.375 for 

cases of AIDS with ranges from 0.0 to 

0.5. (Ref. 25). 

As discussed earlier, the derived 

societal WTP to avoid a statistical 

mortality has been estimated to equal 

approximately $5 million. 

Using these estimates, the WTP to 

avoid the statistical probability of an 

HIV transmission in health care 

personnel is calculated as the sum of: 

• 20 percent of the PV (at 3-percent 

and 7-percent discount rates) of 

avoiding 40 years of HIV infection. 

• 32 percent of the sum of the PV of 

avoiding 5 years of a HIV infection plus 

the PV of avoiding 35 years of AIDS 

infection occurring 5 years in the future. 

• 48 percent of the sum of the PV of 

avoiding 5 years of HIV infection plus 

the PV of avoiding 5 years of AIDS 

infection occurring 5 years in the future 

plus the discounted WTP of avoiding a 

statistical mortality occurring 10 years 

in the future. 

The PV of avoiding 40 years of health 

loss valued at $68,000 per year (3 

percent) is approximately $1.6 million 

and if valued at $120,000 per year (7 

percent) is also approximately $1.6 

million. Twenty percent of this figure 

equals $320,000. 

The PV of avoiding 5 years of health 

loss to due HIV infection is equal to 

$311,000 (3 percent) or $492,000 (7 

percent). The PV of avoiding the health 

loss expected from 35 years of AIDS 

infection (valued at $97,000 (3 percent) 

and $170,000 (7 percent) per year) is 

equivalent to $2.1 million (3 percent) 

and $2.2 million (7 percent). The 

present values of these amounts 

occurring 5 years in the future are $1.8 

million (3 percent) and $1.6 million (7 

percent). When added to the PV of 

avoiding the health loss associated with 

5 years of HIV infection ($311,000 (3 

percent) and $492,000 (7 percent)), the 

total estimated PV of the societal WTP 

to avoid a statistical case of this 

outcome is about $2.1 million (for both 

3-percent and 7-percent discount rates). 

Thirty-two percent of this figure equals 

$660,000. 

The PV of avoiding the health loss 

associated with 5 years of AIDS 

infection ($445,000 (3 percent) and 

$700,000 (7 percent)) occurring 5 years 

in the future is equivalent to $384,000 

(3 percent) and $497,000 (7 percent). 

The PV of the societal value of avoiding 

a statistical mortality ($5 million) 10 

years in the future is $3.72 million (at 

3 percent) and $2.54 million (at 7 

percent). The total societal WTP to 

avoid a case of HIV with mortality as an 

outcome, therefore, is $4.4 million using 

a 3-percent discount rate ($311,000 plus 

$384,000 plus $3.72 million) and $3.5 

million using a 7-percent discount rate 

($493,000 plus $497,000 plus $2.54 

million). Forty-eight percent of these 

figures equals approximately $2.1 

million (3 percent) and $1.7 million (7 

percent). 

Summing the weighted amounts of 

the three expected outcomes for a case 

of HIV infection equals an estimated 

societal WTP of $3.08 million using a 3- 

percent discount rate ($320,000 plus 

$660,000 plus $2.1 million) and $2.68 

million using a 7-percent discount rate 

($320,000 plus $660,000 plus 

$1,700,000). 

In sum, the estimated societal values 

of avoiding morbidity and mortality due 

to transmission of blood-borne 

pathogens are estimated to be equivalent 

to $1.25 million per transmission of 

chronic HBV and $3.08 million per 

transmission of HIV using a 3-percent 

discount rate and $1.24 million per 

transmission of HBV and $2.68 million 

per transmission of HIV using a 7- 

percent discount rate. FDA notes that 

other cost-effectiveness research has 

determined cost-effectiveness estimates 

(excluding pain and suffering) of $2.1 

million per avoided case of HIV. (Ref. 

26). 

FDA believes the methodology used 

to estimate the value of avoided HBV 

and HIV infection is reasonable and 

supportable. However, comparative 

methodologies that demonstrate both 

higher and lower values on avoidance 

have been reported. FDA acknowledged 

these differences in the proposed rule 

and solicited comment on other 

appropriate measures for estimating the 

societal value of avoiding blood-borne 

pathogens. FDA received no responses. 

c. Benefit of morbidity avoidance. The 

rule is expected to reduce both HBV and 

HIV transmissions by reducing the 

prevalence of defective medical gloves 

used as barrier protection. During the 

first evaluation year, the rule is 

expected to result in 0.6 fewer chronic 

HBV transmissions to health care 

personnel. Applying the assumed 

societal WTPs of $1.25 million (3 

percent) and $1.24 million (7 percent) to 

avoid the probability of an HBV 

infection, the expected benefit of 

avoiding these transmissions is $0.8 

million (3 percent) and $0.7 million (7 

percent). By the 10th evaluation year, 

0.8 annual transmissions are expected to 

be avoided at a value of $1.0 million for 

either discount rate. The PV of avoiding 

approximately 7 chronic HBV 

transmissions over a 10-year period 

equals $7.6 million (at 3-percent 

discount rate) and $6.1 million (at 7- 

percent discount rate). This is equal to 

an average annualized value of $0.9 

million for the entire 10-year evaluation 

period at either discount rate. 

Also, in the first evaluation year, FDA 

expects that the final rule will result in 

the probability of 0.6 fewer 

transmissions of HIV caused by 

defective gloves. Assuming that society 

is WTP $3.08 million (at 3-percent 

discount rate) and $2.68 million (at 7- 

percent discount rate) to avoid the 

probability of a single HIV transmission, 

the benefit of avoiding these 

transmissions equals $1.8 million (3 

percent) and $1.6 million (7 percent). By 

the 10th evaluation year, FDA expects 

the final rule to result in 0.8 fewer HIV 

transmissions, which are valued at $2.5 

million (3 percent) and $2.1 million (7 

percent). The societal PV of avoiding 

seven transmissions of HIV over the 10- 

year evaluation period is $18.8 million 

(at 3-percent discount rate) and $13.1 

million (at 7-percent discount rate). 

These values are equivalent to average 

annualized benefits of $2.2 million (at 3- 

percent discount rate) and $1.9 million 

(at 7-percent discount rate). 

In sum, FDA estimates that the 

reduction in blood-borne pathogen 

transmissions due to this final rule 

should produce health benefits valued 

at $3.1 million (at 3-percent discount 

rate) and $2.8 million (at 7-percent 

discount rate) per year. Most of this 

benefit (over 67 percent) is attributable 

to reducing the incidence of HIV. 

6. Value of Avoiding Unnecessary Blood 

Screens 

The expected decline in the number 

of defective medical gloves should lead 

to fewer unnecessary blood screens and 

thereby provide two potential benefits. 

First, the direct cost of conducting 

screens to determine whether the 

pathogen was transmitted to health care 

personnel should decrease. Second, the 

psychological anxiety and stress that 

accompanies the possibility that a 

pathogen was transmitted to an 

individual should also decrease. 

a. Cost of conducting blood screens. 

FDA has collected data from the 

American Red Cross on the costs of 

conducting blood screening tests in 

order to ensure the safety of the blood 

supply. These estimates include the 

costs of collection (including personnel, 


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needles, bags, and other supplies) at 

$47.66 per sample; sample testing at 

$25.16 per sample; and overhead at 

$3.26 per sample. The estimated direct 

testing cost per blood sample is the sum 

of these amounts, or $76 per test (Ref. 

27). 

b. Anxiety and stress associated with 

potential transmission of pathogens. 

The psychological literature has noted 

that levels of anxiety and stress impact 

participation in public health screening 

programs and thereby affect 

physiological health (Ref. 28). Also, 

patients with high levels of uncertainty 

about whether they have contracted 

serious, threatening diseases experience 

heightened levels of stress and anxiety 

until they learn the results of any testing 

screens are negative (Ref. 29). According 

to one measurement scale of well-being, 

reduced mental lucidity, depression, 

crying, lack of concentration, or other 

signs of adverse psychological sequelae 

may detract as much as 8-percent from 

overall feelings of well-being and have 

outcomes similar to physiological 

morbidity (Ref. 30). Scaling of the 

relative stress caused by events shows 

that concerns about personal health, by 

themselves, are likely, on average, to 

contribute approximately one-sixth of 

the total weighting required to trigger a 

major stressful episode (Ref. 31). Thus, 

FDA approximates that increased stress 

and anxiety concerning possible 

exposure to pathogens may reduce 

overall sense of well-being and result in 

health loss of approximately 1.3 percent 

(0.013). 

As described earlier, FDA has 

calculated an assumed WTP of $213,000 

(at 3 percent) and $373,000 (at 7 

percent) for a statistical QALY. These 

figures imply that the probability of 

each day of quality adjusted life has a 

social value of about $585 (at 3-percent 

discount rate; $213,000 divided by 365) 

and $1,020 (at 7-percent discount rate; 

$373,000 divided by 365). If blood test 

results are usually obtained within 24 

hours, the resultant loss of societal wellbeing for each test subject is valued at 

approximately $8 (at 3-percent discount 

rate; $585 x 0.013) and $13 (at 7-percent 

discount rate, $1,020 x 0.013). 

c. Benefit of test avoidance. By 

combining avoided direct costs of tests 

and the value of avoided anxiety and 

stress, FDA estimates that the societal 

benefit of avoiding an unnecessary 

blood test is $84 per sample (at 3- 

percent discount rate) and $89 per 

sample (at 7-percent discount rate). 

During the first evaluation year, FDA 

expects that there will be 120,000 fewer 

unnecessary blood screens because of 

the expected reduction in defective 

medical gloves due to the final rule. The 

implied societal WTP to avoid these 

unnecessary screens is $10.1 million (3 

percent) and $10.7 million (7 percent). 

During the 10th evaluation year, 

approximately 155,000 fewer 

unnecessary blood screens are expected 

with a resultant benefit of $13.0 million 

(3 percent) and $14.0 million (7 

percent). The PV of each year’s reduced 

cost of testing and anxiety totals $100.0 

million (at 3-percent discount rate) and 

$86.4 million (at 7-percent discount 

rate). The average annualized equivalent 

amounts are $11.7 million (3 percent) 

and $12.3 million (7 percent). Between 

85 percent and 90 percent of the average 

annualized amounts represent 

reductions in the direct testing costs 

rather than the reduced anxiety 

associated with possible infection by a 

contagious agent. 

7. Total Benefits 

FDA estimates that the final rule will 

reduce the availability of defective 

medical gloves by over 25 percent, 

resulting in over 2.8 billion fewer 

defective gloves over a 10-year period. 

During this time, FDA expects that the 

reduction in defective gloves will result 

in approximately 7 fewer cases of 

chronic HBV, 7 fewer cases of HIV, and 

1.4 million fewer unnecessary blood 

screens. Based on an implied societal 

WTP, the average annualized benefits of 

the fewer pathogen transmissions and 

unnecessary blood screens should equal 

$14.8 million (at 3-percent annual 

discount rate) and $15.1 million (at 7- 

percent discount rate). 

G. Conclusion 

As noted in the introduction to the 

analysis of impacts section, FDA is 

certifying that the final rule will not 

have a significant impact on a 

substantial number of small entities. We 

provided the above information to 

explain the costs and benefits of the 

rule. There are currently over 400 

manufacturers of medical gloves, a vast 

majority of which are foreign and not 

covered by the Regulatory Flexibility 

Act. There will be little to no impact on 

domestic entities. Moreover, FDA does 

not expect any increased manufacturer 

costs to be directly passed on to end 

users because the cost increases will 

affect only a minority of global 

manufacturers and, therefore, 

competition will likely force these 

manufacturers to absorb these costs. 

The estimated annualized costs equal 

$6.6 million using either a 3-percent 

annual discount rate or a 7-percent 

annual discount rate. Benefits of 

avoiding transmissions of blood-borne 

pathogens and unnecessary blood 

screens have been estimated to equal 

$14.8 million (using a 3-percent 

discount rate) or $15.1 million (using a 

7-percent discount rate). The final rule 

is estimated to result in average 

annualized net benefits of $8.2 million 

(using a 3-percent discount rate) or $8.5 

million (using a 7-percent discount 

rate).’’

2. On page 75875, in the second 

column, section V of the document is 

corrected to read: 

‘‘V. References 

The following references have been 

placed on display in the Division of 

Dockets Management and may be seen 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday. 

FDA has verified the Web site 

addresses, but is not responsible for 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register. 

1. Centers for Disease Control and 

Prevention (CDC), ‘‘HIV/AIDS Surveillance 

Report,’’ (vol. 12, no. 2) (pp 5–6), http:// 

www.cdc.gov/hiv/topics/surveillance/ 

resources/reports/pdf/hasr1202.pdf, 2000. 

2. CDC, ‘‘Fact Sheet: Surveillance of Health 

Care Workers With HIV/AIDS,’’ http:// 

www.cdc.gov/hiv/pubs/facts/hcwsurv.htm, 

2001. 

3. Id. 

4. CDC, ‘‘Fact Sheet: Viral Hepatitis B,’’

http://www.cdc.gov/ncidod/diseases/ 

hepatitis/b/fact.htm, 2003. 

5. Id. 

6. Id. 

7. CDC, Morbidity and Morality Weekly 

Report, ‘‘Updated U.S. Public Health Service 

Guidelines for the Management of 

Occupational Exposures to HBV, HCV, and 

HIV and Recommendations for Postexposure 

Prophylaxis,’’ http://www.cdc.gov/mmwr/ 

preview/mmwrhtml/rr5011a1.htm, 2001. 

8. CDC, ‘‘Fact Sheet: Viral Hepatitis C,’’

http://www.cdc.gov/ncidod/diseases/ 

hepatitis/c/fact.htm, 2003. 

9. Id. 

10. U.S. International Trade Commission, 

Interactive Tariff and Trade Dataweb: Import 

Statistics, (Data file), available from http:// 

dataweb.usitc.gov/, 2004. 

11. Eastern Research Group, Inc., ‘‘Cost 

Analysis of the Labeling and Related Testing 

Requirements for Medical Glove 

Manufacturers (Table 2),’’ Lexington, MA: 

Eastern Research Group, Inc., March 2002. 

12. Bureau of Labor Statistics, ‘‘Career 

Guide to Industries: Health Services,’’ http:// 

www.bls.gov/oco/cg/cgs035.htm, 2002-2003. 

13. Winchester Engineering & Analytical 

Center, Office of Regulatory Affairs Web 

Reports (data file), available from http:// 

webrpt.ora.fda.gov (follow ‘‘Access 

Reports’’), 2001. 

14. Id. 

15. Id. 

16. Id. 

17. Character, B. J., R. M. McLaughlin, C. 

S. Hedlund, et al., ‘‘Postoperative Integrity of 

Veterinary Surgical Gloves,’’ Journal of the 


frosa on PROD1PC71 with RULES
2444 Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Rules and Regulations 

American Animal Hospital Association, 39, 

pp. 311 to 320, May/June 2003. 

18. Mudarri, D. H., ‘‘The Costs and Benefits 

of Smoking Restrictions: An Assessment of 

the Smoke-Free Environment Act of 1993,’’

(H.R. 3434) (p. 14), Washington, DC, U.S. 

Environmental Protection Agency, April 

1994. 

19. Mudarri, D. H., ‘‘The Costs and Benefits 

of Smoking Restrictions: An Assessment of 

the Smoke-Free Environment Act of 1993,’’

(H.R. 3434) (Appendix A–1), Washington, 

DC, U.S. Environmental Protection Agency; 

Kaplan, R. M., J. W. Bush, & C. C. Berry, 

Health Status: Types of Validity and the 

Index of Well-Being, Health Services 

Research Journal, pp. 478–507, winter 1976. 

20. Kaplan, R. M., J. W. Bush, C. C. Berry, 

(1976, Winter), ‘‘Health Status: Types of 

Validity and the Index of Well-Being,’’

Health Services Research Journal, pp. 478–

507; M. M. Chen, J. W. Bush, D. L. Patrick, 

(1975), ‘‘Social Indicators for Health Planning 

and Policy Analysis,’’ Policy Sciences 

Journal, 6, pp. 71–89; R. M. Kaplan, J. W. 

Bush, (1982), ‘‘Health Related Quality of Life 

Measurement for Evaluation Research and 

Policy Analysis,’’ Health Psychology, 1(1), 

pp. 61–80. 

21. R. M. Kaplan, J. W. Bush, C. C. Berry, 

‘‘Health Status: Types of Validity and the 

Index of Well-Being,’’ Health Services 

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Dated: January 11, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–682 Filed 1–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2006–HA–0194; RIN 0720–AB07] 

TRICARE; Certain Survivors of 

Deceased Active Duty Members; and 

Adoption Intermediaries 

AGENCY: Office of the Secretary, DoD. 

ACTION: Interim Final Rule. 

SUMMARY: This interim final rule 

implements two provisions of the 

National Defense Authorization Act for 

Fiscal Year 2006 (NDAA FY06), Public 

Law 109–163. First, Section 715 of the 

NDAA FY06 extends the time frame 

certain dependents of Active Duty 

Service Members (ADSM) who die 

while on active duty for more than 30 

days shall receive TRICARE medical 

benefits at active duty dependent 

payment rates. Second, Section 592 of 

the NDAA FY06 modifies the 

requirement for those intermediaries 

who provide adoption placements. 

Additionally, this interim final rule 

makes an administrative clarification to 

the following two eligibility provisions: 

those placed in the legal custody of a 

member or former member; and those 

placed in the home of a member or 

former member in anticipation of 

adoption. This clarification makes a 

distinction between the two groups and 

specifies that for placement into legal 

custody by court order, the court order 

must be for a period of 12 consecutive 

months. 

Public comments are invited and will 

be considered for possible revisions to 

the final rule. 

DATES: This rule is effective March 20, 

2007. 

Comments: Written comments 

received at the address indicated below 

by March 20, 2007 will be accepted. 

ADDRESSES: You may submit comments, 

identified by docket number and or RIN 

number and title, by any of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 1160 Defense Pentagon, 

Washington, DC 20301–1160. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulatory 

Information Number (RIN) for this 

Federal Register document. The general 

policy for comments and other 

submissions from members of the public 

is to make these submissions available 

for public viewing on the Internet at 

http://regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Ann N. Fazzini, (303) 676–3803 for 

questions regarding Section 715 as it 

relates to the TRICARE Basic Program; 

and also questions regarding Section 

592. 

Mr. Michael Kottyan, (303) 676–3520 

for questions regarding Section 715 as it 

relates to the Extended Health Care 

Option (ECHO). 

Mr. John Leininger, (303) 676–3613, 

for questions regarding TRICARE Prime 

Remote. 

Questions regarding payment of 

specific claims should be addressed to 

the appropriate TRICARE contractor. 

SUPPLEMENTARY INFORMATION: The 

Department is publishing this rule as an 

interim final rule in order to meet 

statutorily required effective dates. The 

Department is not exercising any 

discretion in implementing these 

provisions. In accordance with Section 

715(b), the effective date for Section 715 

is October 7, 2001 and shall apply with 

respect to deaths occurring on or after 

that date. The Department has no 

discretion concerning the benefits 

available to surviving dependents, the 

effective date, nor the time periods 

benefits are available to surviving 

spouses and children respectively. The 

effective date for Section 592 is January 

6, 2006. Prior to the NDAAFY06, a child 

placed in the home by a placement 

agency recognized by the Secretary of 

Defense in anticipation of the legal 

adoption of the person was eligible for 

TRICARE. Section 592 of the NDAA 

FY06 expands those intermediaries who 

perform adoption placement to include 

placement by any source authorized by 

State or local law to provide adoption 

placement. The Department is not 

exercising any discretion in defining 

who are intermediaries who can 

perform adoption placement. In 

accordance with Public Law 103–160, 

section 702(b), the effective date for 

placement by a court is July 1, 1994. In 

accordance with Public Law 103–337, 

section 701, the effective date for 

placement by a recognized adoption 

agency October 5, 1994. These last two 

changes are administrative corrections 


frosa on PROD1PC71 with RULES